Further Validation Documents

In a non compensating HEPA flow regime a dirty filter will progressively reduce the room airflow. This can resultant in insufficient air flow to protect staff and or the product, it can be dangerous for both. If you started with an actual flow that was only 40% of the rated flow, the filter would be seriously blocked before you reached the un-corrected dirty filter change PD. This is why regulators will ask for the filter clean DP justification calculations.

This operation is documented as a Method Statement, however you can include it in SOP format. The most important thing is that you have it, and you have used it to justify your clean pressure drop (PD) across your HEPA filters. If this justification is not carried out you can compromise the integrity of your room / machine pressure regimes. As you are no doubt aware this would be a very serious state to be in. There are also health and safety problems that can arise, if personnel are not getting the air flow protection that is sometimes designed into the system. This is simply documented and easy to follow.

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